A Single Center, Single Arm, Pilot Study Assessing Efficacy and Safety of Herbal Powder in Patients with Functional Constipation.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in frequency of bowel movements and changes in stool form assessed using the “Bristol stool form scale.
研究概览
简要总结
Constipation is a common gastrointestinal complaint in apparently healthy populations as well as in patients with various predisposing disorders. Functional constipation can be caused by lifestyle factors, psychological factors and behavioural factors; withholding behaviour is a key factor in the Pathophysiology of childhood functional constipation, whereas adults often have dyssynergic defaecation patterns.
Factors involved in constipation include low fiber diet, caffeine abuse, overuse of alcohol, medications, endocrine disorders (hypothyroid), neurologic disease (neuropathy) and psychological issues.
A comprehensive medical history and physical examination are the foundation for the diagnosis of functional constipation; further testing is only necessary if alarming symptoms are present or conventional treatments are unsuccessful.
Anorectal malformations, pelvic/rectal masses, rectal prolapse, rectocele, dysfunctional voiding, pelvic floor dyssynergia, internal anal sphincter hypertonicity, and achalasia should all be ruled out before functional constipation is diagnosed. Hirschsprung disease and visceral myopathies or neuropathies should both be ruled out as colorectal diseases.
Colorectal conditions should be ruled out, including visceral myopathies or neuropathies, as well as Hirschsprung disease. Systemic conditions, psychosocial issues, drugs or toxins need to be identified.
The Pathophysiology underlying functional constipation is multifactorial and not well understood. Factors that may contribute to functional constipation include pain, fever, dehydration, dietary and fluid intake, psychological issues, toilet training, medicines, and family history of constipation.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Male/Female participants ≥18 years of age at the time of consent
- •Participants with loose stool being rarely present without the use of laxatives
- •Participants with insufficient criteria for irritable bowel syndrome
- •Participants presenting with two or more of the following for the last three months with symptom onset at least six months prior to diagnosis: (a) Straining during at least 25% of defecations (b) Lumpy or hard stools at least 25% of defecations (c) Sensation of incomplete evacuation at least 25% of defecations (d) Sensation of anorectal obstruction/blockage at least 25% of defecations (e) Manual maneuvers to facilitate at least 25% of defecations, eg: digital evacuation, support of the pelvic floor (f) Fewer than three defecations per week and those in whom loose stools were rarely present without the use of laxatives]
- •Female participant of non-childbearing potential, including any female who: a) has had a hysterectomy, b) has had a bilateral oophorectomy, c) has had a bilateral tubal ligation or d) is post-menopausal (demonstration of total cessation of menses for ≥ 1 year from the date of the screening visit)
- •Female participants of childbearing potential who agree to use two forms of contraception, one of which must be a barrier method, during the full duration of the study
- •Participants with a stool form score ranging from 1 to 3 on the “Bristol Stool Form Scale"
- •Participants/ Legally Acceptable Representative who are willing to provide written Informed Consent and comply with study procedures.
排除标准
- •1 Participants with obstructive disorders and neurologic problems 2 Participants taking concomitant medications which are known to cause constipation like opioid analgesics, antidepressants, i.e., amitriptyline and imipramine, anticonvulsants, and aluminum-containing antacids) 3 Participants on chronic laxative medication(Greater than 60 days) 4 Participants with IBS, Belching disorders, etc.
- •participants with a history of abdominal or anorectal surgery in the past one year and those with renal or liver dysfunction or colonic inertia or structural abnormalities of gastro-intestinal tract or uncontrolled systemic ailments (like Human immunodeficiency virus, Diabetes mellitus, and Tuberculosis) or neurological problems (like Parkinson’s disease, multiple sclerosis, sacral nerve damage, and paraplegia or autonomic neuropathy) 5 Participants who are allergic to any of the ingredients of the investigational product 6 Pregnant and female lactating women at the time of screening 7 Participants with any condition which makes the subject unsuitable for study participation which as per the investigator would jeopardize the outcome of the trial or participant who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol.
结局指标
主要结局
Changes in frequency of bowel movements and changes in stool form assessed using the “Bristol stool form scale.
时间窗: Day 1,Day 7,Day 15.
次要结局
- 1. a. Changes in the following symptoms:(- straining on defecation)
研究者
Dr S Chikkalingaiah
Medstar Speciality Hospital